LiveyonSeptember 21, 2018

FDA 483 - Liveyon - September 21, 2018

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Record Details

An FDA inspection of Liveyon, an own label stem cell distributor in Yorba Linda, CA, revealed serious deficiencies across its operations. The firm failed to report multiple fatal or life-threatening adverse reactions involving communicable diseases related to HCT/Ps. Significant issues were also noted in complaint handling, communicable disease testing interpretation, product release criteria, equipment calibration, HCT/P storage, and shipping conditions.

Company: Liveyon
Inspection Date: September 21, 2018
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Thanh B. Tran (Recall Coordinator)
Tania Y. Hall

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ID · 98e56818-e186-46c3-935f-6ef233e45d0b